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Study for Atrial Fibrillation Reduction (SAFARI)

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ClinicalTrials.gov Identifier: NCT00267137
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : May 25, 2018
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

December 19, 2005
December 20, 2005
May 25, 2018
September 2002
Not Provided
Safety/Efficacy
Same as current
Complete list of historical versions of study NCT00267137 on ClinicalTrials.gov Archive Site
Various
Same as current
Not Provided
Not Provided
 
Study for Atrial Fibrillation Reduction (SAFARI)
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Atrial Fibrillation, Bradycardia
Device: Pacing Algorithms
Not Provided
Gold MR, Hoffmann E; SAFARI Investigators. Rationale and design of a randomized clinical trial to assess the role of overdrive and triggered prevention pacing therapies in reducing atrial fibrillation: the Study of Atrial Fibrillation Reduction (SAFARI). Am Heart J. 2006 Aug;152(2):231-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
Same as current
Not Provided
Not Provided

Inclusion Criteria:

  • Subjects with a slow heartbeat who are in need of dual chamber pacing (pacing in both the atrium and ventricle).
  • Subjects who have experienced at least two episodes of rapid heart beats three months prior to enrollment.

Exclusion Criteria:

  • Subjects who have a history of permanent (chronic) or persistent (non self-terminating) atrial fibrillation.
  • Subjects with atrial fibrillation due to reversible cause, (e.g. thyroid disease, pericarditis, post-surgery, alcohol abuse).
  • Subjects with a history of one or more cardioversions (changing an abnormal heart rhythm into a normal one by either using medication or by the application of an electric shock) six months prior to enrollment.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00267137
190
Not Provided
Not Provided
Not Provided
Not Provided
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Investigator: Not Required For IDE Studies
Medtronic Cardiac Rhythm and Heart Failure
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP